Synovectomy in Primary Total Knee Arthrplasty

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Synovectomy Versus no Synovectomy in Primary Total Knee Arthrplasty : A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03778463
• Other study ID #: 12370677
• Status: Recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: December 2020

Study information

• Verified date: December 2018
• Source: Ain Shams University
• Contact: Ahmed Saeed Younis, Dr.
• Phone: 201012370677
• Email: ahmed.s.younis[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized clinical trial trying to reach the best evidence in that matter.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with primary osteoarthritis undergoing primary total knee arthroplasty

Exclusion Criteria:

• Inflammatory arthritis

• Revision knee arthroplasty

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Synovectomy

Intervention

Other:
• Synovectomy
Removal of the synovium during total knee arthroplasty

Locations

Country	Name	City	State
Egypt	Ain Shams Univrsity	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome scores. e.g. knee society score (KSS)		one year
Primary	knee pain e.g. visual analogue score (VAS) score		immediate postoperative
Primary	Health related quality of life e.g. short form (SF12) scale		one year
Primary	Revision rate		one year
Primary	Reoperation rate		one year
Primary	Range of motion		immediate postoperative
Primary	Range of motion		6 month
Primary	Range of motion		One year
Secondary	Postoperative blood loss		immediate postoperative
Secondary	Postoperative hemoglobin level	gram/dl	immediate postoperative
Secondary	Infection rate		in first three month
Secondary	Wound complications		in first 3 months
Secondary	Number of patients requiring transfusion		immediate postoperative